Sr. Manager, Regulatory Asset Oversight

Basic Qualification: 16 - 21 Years of professional experience. Experience in Regulatory life Cycle till Phase 4. Location - Bangalore. Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSKIf so, this Manager, Regulatory Asset Oversight role could be an ideal opportunity to explore. As Manager, Regulatory Asset Oversight, you will manage multiple projects and teams simultaneously and will provide assessments (metrics, data) and conclusions/action plans within and across departments. You ll identify risks associated with submission data and information packages, and lead in the creation, maintenance and continuous improvement of Regulatory processes, policies and systems. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following

• In close collaboration with the GRL and RMT, develop and maintain a holistic view of the global regulatory integrated plan at the asset level for operationalizing the Global Regulatory Strategy and supporting the GRL in ensuring appropriate resource is engaged to deliver to the plan,
• Drive the execution of the agreed plans to ensure team is on-track to deliver per the Global Regulatory Strategy (GRS), performing scenario planning, impact analyses, critical path analyses and facilitate risk mitigation in response to any issues/risks that arise.
• Leverage expertise to assist RMTs and GRLs with submission delivery strategies that align with R&D objectives, e.g. Hyper-Acceleration, Acceleration in regions.
• Implement a structured approach with assigned RMTs to ensure that the submission delivery strategy is aligned with the Global Submission Strategy (GSS) throughout the late-stage Development lifecycle.
• Proactively partner as a Single Point of Contact with RMT, Submission Coordination, and Publishing colleagues to identify and remove barriers that will prevent a successful outcome on defined filing strategies.
• Drive the RMT Meeting and other Cross-Functional, Regulatory-Owned Engagements for success ensuring logistics, agenda topics and meeting materials are available and organized for the use of the team.
• Proactively identifies upcoming activities or milestones which might impact regulatory deliverables and escalates of issues and blockers to the Director, Regulatory Asset Oversight, and leadership.
• Promote and drive the use of integrated Regulatory technologies to provide real-time, accurate submission status information (visuals and reports) for RMTs to highlight compliance from central dispatches through to registrations across markets. Maintains meaningful metrics and KPIs to assess individual and team performance which are aligned across the Regulatory Asset Oversight function.
• Support the GRL in the preparation of governance reviews leveraging data from RIM systems and ensuring accuracy, completeness, and fit for purpose.
• Facilitate discussions with LOCs and RMTs as needed to ensure aligned submission delivery strategy and efficient lifecycle filing strategies from lead markets through to regional expansion.

Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:

• Bachelor s Degree
• Extensive knowledge of drug development and manufacturing and supply processes.
• Broad and deep knowledge of worldwide regulatory requirements.
• Successfully managed multiple projects

Preferred Qualifications: If you have the following characteristics, it would be a plus:

• Degree in Chemistry, pharmacy or closely related science
• Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies.
• Broad knowledge base across regulatory functions.
• Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings.
• Line management experience